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Singapore HSA registration DE0508572

Leica Microsystems GLOW400

Singapore flagSingapore·CLASS B·Leica Microsystems (Schweiz) AG·Registered October 16, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0508572
Registration Date
October 16, 2023
Change Notification Approval Date
July 04, 2024
Retention Due Date
October 15, 2025
Product description
GLOW400 is a digital surgical microscope accessory for viewing fluorescence of fluorophores with an excitation peak between 380nm and 430nm and an observation comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444nm. GLOW400 is intended for visualization of fluorescence with improved visualization of the anatomical background and for visualization of the enhanced fluorescence contrast. GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
Product Owner
Name
Leica Microsystems (Schweiz) AG
Short Name
Leica Microsystems (Schweiz) AG
Address
Max Schmidheiny Str. 201, 9435 Heerbrugg, SWITZERLAND
Registrant
Name
LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
Name
LEICA INSTRUMENTS (SINGAPORE) PTE LIMITED LEICA MICROSYSTEMS (SEA) PTE LTD
Address
15 TUKANG INNOVATION DRIVE, SINGAPORE 618299 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
Model Name(s)
GLOW400
Model Identifier(s)
10449184
About this record

Access comprehensive regulatory information for Leica Microsystems GLOW400 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508572 and owned by Leica Microsystems (Schweiz) AG. The device was registered on October 16, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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